Pulmonary Embolism Response Team utilization during the COVID-19 pandemic.

Coronavirus disease 2019 (COVID-19) may predispose patients to venous thromboembolism (VTE). Limited data are available on the utilization of the Pulmonary Embolism Response Team (PERT) in the setting of the COVID-19 global pandemic. We performed a single-center study to evaluate treatment, mortality, and bleeding outcomes in patients who received PERT consultations in March and April 2020, compared to historical controls from the same period in 2019. Clinical data were abstracted from the electronic medical record. The primary study endpoints were inpatient mortality and GUSTO moderate-to-severe bleeding. The frequency of PERT utilization was nearly threefold higher during March and April 2020 (n = 74) compared to the same period in 2019 (n = 26). During the COVID-19 pandemic, there was significantly less PERT-guided invasive treatment (5.5% vs 23.1%, p = 0.02) with a numerical but not statistically significant trend toward an increase in the use of systemic fibrinolytic therapy (13.5% vs 3.9%, p = 0.3). There were nonsignificant trends toward higher in-hospital mortality or moderate-to-severe bleeding in patients receiving PERT consultations during the COVID-19 period compared to historical controls (mortality 14.9% vs 3.9%, p = 0.18 and moderate-to-severe bleeding 35.1% vs 19.2%, p = 0.13). In conclusion, PERT utilization was nearly threefold higher during the COVID-19 pandemic than during the historical control period. Among patients evaluated by PERT, in-hospital mortality or moderate-to-severe bleeding were not significantly different, despite being numerically higher, while invasive therapy was utilized less frequently during the COVID-19 pandemic.

Low venous thromboembolism incidence in high risk medical patients in an Israeli hospital. Can risk assessment be extrapolated to different populations?

BACKGROUND: Guidelines recommend venous thromboembolism (VTE) prophylaxis in hospitalized medical patients with Padua prediction score (PPS) ≥4 points. This recommendation is based on the high risk of symptomatic VTE observed among these patients in the Italian PPS derivation study, and the fivefold risk reduction with VTE-prophylaxis. This study aims to assess the incidence of VTE in high risk medical patients in a medium sized hospital in Israel. METHOD: In this retrospective cohort study, data was collected of all medical patients hospitalized between January and June 2014. Patients were classified into low and high risk groups according to their PPS score, and according to whether they received anticoagulant thromboprophylaxis for VTE. Patients were further randomly selected to compare high risk patients that did or did not receive anticoagulant thromboprophylaxis. We further compared VTE incidence in high and low risk patients not treated with thromboprophylaxis. A search was conducted for diagnoses of venous thromboembolism and death during hospitalization and the following 90 days. RESULTS: 568 high risk patients (PPS ≥4 points) were included, 284 treated with prophylactic anticoagulation and 284 not. There were no VTE events in either group. There was no difference in mortality. A total of 642 non anticoagulated patients were randomly selected, 474 low risk and 168 high risk. There were no VTE events in either group. CONCLUSIONS: The risk of VTE appears to be very low in our study, suggesting that among medical patients with PPS ≥4, the risk of VTE may differ dramatically between populations.

The effect of catheter-directed thrombolytic use on readmission rates and in-hospital outcomes among cancer patients with venous thromboembolism in the United States.

BACKGROUND: Cancer inducing a hypercoagulable state, venous thromboembolism (VTE) remains a leading cause of morbidity and mortality globally. We assessed the impacts of cancer on the likelihood for readmission after a VTE-targeted procedure. METHODS: We created a new cohort using discharge-level data from all hospitalizations from State Inpatient Databases of geographically dispersed participating states (18-27 states). RESULTS: In those presenting with VTE during index-admission (619 241), 2.4% patients underwent catheter directed thrombolytic therapy (CDL) on index admission and among those 20.3% had cancer. Moreover, the 30-day readmission rate amongst CDL recipients (10 776 overall) was 14.3% in those with cancer compared to 8.8% in those with no cancer history (P < .0001). Additionally, in-hospital mortality (5.7% vs 1.1%; P = 0.009) and cost-of-care ($11 014 ± 914 vs $10 520 ± 534; P = .04) was significantly higher in cancer compared to noncancer. CONCLUSION: The use of CDL does not appear to reduce the risk of returning for a VTE-related admission in cancer.

Cost-Benefit Limitations of Extended, Outpatient Venous Thromboembolism Prophylaxis Following Surgery for Crohn's Disease.

BACKGROUND: Patients with Crohn's disease are at increased risk of postoperative venous thromboembolism. Historically, extended outpatient prophylaxis has not met conventional measures of societal cost-benefit advantage. However, extended prophylaxis for patients with Crohn's disease may be more cost-effective because of the patients' high thrombotic risk and long life expectancy. OBJECTIVE: This study aimed to assess the cost-effectiveness of extended prophylaxis in patients with Crohn's disease after abdominal surgery. DESIGN: A decision tree model was used to assess the incremental cost-effectiveness and cost per case averted with extended-duration venous thromboembolism prophylaxis following abdominal surgery. SETTING: The risk of a postdischarge thrombotic event, age at surgery, type of thrombotic event, prophylaxis risk reduction, bleeding complications, and mortality were estimated by using existing published sources. PATIENTS: Studied were patients with Crohn's disease versus routine care. INTERVENTION: We constructed a decision analysis to compare costs and outcomes in patients with Crohn's disease postoperatively with and without extended prophylaxis over a lifetime horizon. MAIN OUTCOME MEASURES: Productivity costs ($) and benefits (quality-adjusted life-year) were used to reflect a societal perspective and were time discounted at 3%. Multivariable probabilistic sensitivity analysis accounted for uncertainty in probabilities, costs, and utility weights. RESULTS: With the use of reference parameters, the individual expected societal total cost of care was $399.83 without and $1387.95 with prophylaxis. Preventing a single mortality with prophylaxis would cost $43.00 million (number needed to treat: 39,839 individuals). The incremental cost was $1.90 million per quality-adjusted life-year. Adjusting across a range of scenarios upheld these conclusions 88% of the time. With further sensitivity testing, subpopulations with postdischarge thrombosis rates greater than 4.9% favors postoperative extended-duration venous thromboembolism prophylaxis. LIMITATIONS: Further investigation is needed to determine if specific high-risk individuals can be preemptively identified in the Crohn's surgical population for targeted prophylaxis. CONCLUSION: Extended prophylaxis in patients with Crohn's disease postoperatively is not cost-effective when the cumulative incidence of posthospital thrombosis remains less than 4.9%. These findings are driven by the low absolute risk of thrombosis in this population and the considerable cost of universal treatment. See Video Abstract at http://links.lww.com/DCR/A998. LIMITACIONES DE COSTO-BENEFICIO DE LA PROFILAXIS AMBULATORIA PROLONGADA DEL TROMBOEMBOLISMO VENOSO DESPUÉS DE CIRUGÍA EN CASOS DE ENFERMEDAD DE CROHN:: Los pacientes con enfermedad de Crohn tienen un mayor riesgo de tromboembolismo venoso postoperatorio. Históricamente, la profilaxis ambulatoria prolongada no ha cumplido con las medidas convencionales de ventajas en costo-beneficio para la sociedad. Sin embargo, la profilaxis prolongada en los pacientes con Crohn puede ser más rentable debido al alto riesgo trombótico y a una larga esperanza de vida en estos pacientes.Evaluar la rentabilidad de la profilaxis prolongada en pacientes postoperados de un Crohn.Se utilizó un modelo de árbol de decisión para evaluar el incremento de rentabilidad y el costo por cada caso evitado con la profilaxis prolongada de tromboembolismo venoso después de cirugía abdominal.Se calcularon utilizando fuentes publicadas el riesgo de evento trombótico posterior al alta, la edad del paciente al momento de la cirugía, el tipo de evento trombótico, la reducción del riesgo de profilaxis, las complicaciones hemorrágicas y la mortalidad.Se estudiaron los pacientes de atención rutinaria versus aquellos portadores de Crohn.Construimos un arbol de análisis decisional para comparar costos y resultados de pacientes portadores de Crohn, con y sin profilaxis prolongada en el postoperatorio en un horizonte de por vida.Los costos de productividad ($) y los beneficios (año de vida ajustado por calidad) se utilizaron para reflejar la perspectiva social y se descontaron en el tiempo de un 3%. El análisis de sensibilidad probabilística multivariable dió cuenta de la incertidumbre en las probabilidades, costos y peso de utilidades.Usando parámetros de referencia, el costo total social esperado de la atención individual fue de $ 399.83 sin y $ 1,387.95 con profilaxis. La prevención del deceso de un paciente con profilaxis costaría $ 43.00 millones (valor requerido para tratar: 39,839 individuos). El costo incrementado fue de $ 1.90 millones por año de vida ajustado por la calidad. El ajuste a través de una gama de escenarios confirmó estas conclusiones el 88% del tiempo. Con pruebas de sensibilidad adicionales, las subpoblaciones con tasas de trombosis posteriores al alta fueron superiores al 4,9% y favorecían la profilaxis prolongada del tromboembolismo venoso en el postoperatorio.Se necesita más investigación para determinar si se puede identificar de manera preventiva los individuos específicos de alto riesgo en la población quirúrgica de Crohn en casos de profilaxis dirigida.La profilaxis prolongada en pacientes postoperados de un Crohn no es rentable cuando la incidencia acumulada de trombosis posthospitalaria sigue siendo inferior al 4,9%. Estos hallazgos son impulsados por el bajo riesgo absoluto de trombosis en esta población y el costo considerable del tratamiento universal. Vea el resumen del video en http://links.lww.com/DCR/A998.

Association of Acute Venous Thromboembolism With In-Hospital Outcomes of Coronary Artery Bypass Graft Surgery.

Background While venous thromboembolism (VTE) prophylaxis is a strong recommendation after most surgeries, it is controversial in cardiac surgeries such as coronary artery bypass grafting (CABG), because of perceived low VTE incidence and increased bleeding risk. Prior studies may not have been adequately powered to study outcomes of VTE in this population. We sought to investigate the postoperative incidence and outcomes of CABG patients using a large national inpatient database. Methods and Results We utilized the 2013 to 2014 National Inpatient Sample to identify all patients >18 years of age who underwent CABG (without concomitant valvular procedures), and had VTE during the hospital stay. We then compared clinically relevant outcomes in patients with and without VTE. We identified 331 950 CABG procedures. Of these, 1.3% (n=4205) had VTE. Patients with VTE were more likely to be older (mean 67.2±10.4 years versus 65.2±10.4 years, P<0.001). VTE was associated with higher incidence of inpatient mortality (6.8% versus 1.7%; adjusted odds ratio 1.92 [95% CI 1.40-2.65]; P<0.001) and complications. VTE was also associated with higher cost (mean±SE $81 995±$923 versus $48 909±$55) and longer length of stay (mean±SE 17.06±0.16 days versus 8.52±0.01 days). Conclusions Our analysis of >330 000 CABG procedures suggests that while postoperative VTE after CABG is rare, it is associated with increased morbidity and mortality. Randomized controlled trials are needed to identify optimal strategies for VTE prophylaxis in these patients.

Cost-Effectiveness of Extended Thromboprophylaxis in Patients Undergoing Colorectal Surgery from a Canadian Health Care System Perspective.

BACKGROUND: There is increasing evidence to support extended thromboprophylaxis after colorectal surgery to minimize the incidence of postdischarge venous thromboembolic events. However, the absolute number of events is small, and extended thromboprophylaxis requires significant resources from the health care system. OBJECTIVE: This study aimed to determine the cost-effectiveness of extended thromboprophylaxis in patients undergoing colorectal surgery for malignancy or IBD. DESIGN: An individualized patient microsimulation model (1,000,000 patients; 1-month cycle length) comparing extended thromboprophylaxis (28-day course of enoxaparin) to standard management (inpatient administration only) after colorectal surgery was constructed. SETTINGS: The sources for this study were The American College of Surgeons National Surgical Quality Improvement Project Participant User File and literature searches. OUTCOMES: Costs (Canadian dollars), quality-adjusted life-years, and venous thromboembolism-related deaths prevented over a 1-year time horizon starting with hospital discharge were determined. The results were stratified by malignancy or IBD. RESULTS: In patients with malignancy, extended prophylaxis was associated with higher costs (+113$; 95% CI, 102-123), but increased quality-adjusted life-years (+0.05; 95% CI, 0.04-0.06), resulting in an incremental cost-effectiveness ratio of 2473$/quality-adjusted life-year. For IBD, extended prophylaxis also had higher costs (+116$; 95% CI, 109-123), more quality-adjusted life-years (+0.05; 95% CI, 0.04-0.06), and an incremental cost-effectiveness ratio of 2475$/quality-adjusted life-year. Extended prophylaxis prevented 16 (95% CI, 4-27) venous thromboembolism-related deaths per 100,000 patients and 22 (95% CI, 6-38) for malignancy and IBD. There was a 99.7% probability of cost-effectiveness at a willingness-to-pay threshold of 50,000$/quality-adjusted life-year. To account for statistical uncertainty around variables, sensitivity analysis was performed and found that extended prophylaxis is associated with lower overall costs when the incidence of postdischarge venous thromboembolic events reaches 1.8%. LIMITATIONS: Significant differences in health care systems may affect the generalizability of our results. CONCLUSIONS: Despite the rarity of venous thromboembolic events, extended thromboprophylaxis is a cost-effective strategy. See Video Abstract at http://links.lww.com/DCR/A976. COSTO-EFECTIVIDAD DE LA TROMBOPROFILAXIS EXTENDIDA EN PACIENTES SOMETIDOS A CIRUGÍA COLORRECTAL DESDE UNA PERSPECTIVA DEL SISTEMA DE SALUD CANADIENSE:: Cada vez hay más pruebas que apoyen la tromboprofilaxis extendida después de la cirugía colorrectal para minimizar la incidencia de eventos tromboembólicos venosos después del alta hospitalaria. Sin embargo, el número absoluto de eventos es pequeño y la tromboprofilaxis extendida requiere recursos significativos del sistema médico.Determinar la rentabilidad (relación costo-efectividad) de la tromboprofilaxis extendida en pacientes sometidos a cirugía colorrectal por neoplasia maligna o enfermedad inflamatoria intestinal.Un modelo de microsimulación de paciente individualizado (1,000,000 de pacientes; ciclo de 1 mes) que compara la tromboprofilaxis extendida (curso de enoxaparina de 28 días) con el tratamiento estándar (solo para pacientes hospitalizados) después de la cirugía colorrectal.Archivo de usuario participante del Proyecto de Mejoramiento de la Calidad Quirúrgica del Colegio Nacional de Cirujanos Americanos (ACS-NSQIP) y búsquedas bibliográficas.Costos (en dólares Canadienses), años de vida ajustados por la calidad y muertes relacionadas con el tromboembolismo venoso prevenidas en un horizonte temporal de 1 año a partir del alta hospitalaria. Los resultados fueron estratificados por malignidad o enfermedad inflamatoria intestinal.En pacientes con neoplasias malignas, la profilaxis extendida se asoció con costos más altos (+113 $; IC del 95%, 102-123), pero con un aumento de la calidad de vida ajustada por años de vida (+0.05; IC del 95%, 0.04-0.06), lo que resultó en un incremento de relación costo-efectividad de 2473 $/año de vida ajustado por calidad. Para la enfermedad inflamatoria intestinal, la profilaxis extendida también tuvo costos más altos (+116 $; 95% IC, 109-123), más años de vida ajustados por calidad (+0.05; 95% IC, 0.04-0.06) y una relación costo-efectividad incremental de 2475 $/año de vida ajustado por calidad. La profilaxis prolongada evitó 16 (95% IC, 4-27) muertes relacionadas con tromboembolismo venoso por cada 100,000 pacientes y 22 (95% IC, 6-38) por malignidad y enfermedad inflamatoria intestinal, respectivamente. Hubo un 99.7% de probabilidad de costo-efectividad en un límite de disposición a pagar de 50,000 $/año de vida ajustado por calidad. Para tener en cuenta la incertidumbre estadística en torno a los variables, se realizó un análisis de sensibilidad y se encontró que la profilaxis extendida se asocia con menores costos generales cuando la incidencia de eventos tromboembólicos venosos después del alta hospitalaria alcanza 1.8%.Las diferencias significativas en los sistemas de salud pueden afectar la generalización de nuestros resultados.A pesar de la escasez de eventos tromboembólicos venosos, la tromboprofilaxis extendida es una estrategia rentable. Vea el video del resumen en http://links.lww.com/DCR/A976.

Rate and impact of venous thromboembolism in patients with ST-segment elevation myocardial infarction: Analysis of the Nationwide Inpatient Sample database 2003-2013.

Venous thromboembolism (VTE) and coronary artery disease are major health issues that cause substantial morbidity and mortality. New data have emerged suggesting that these two conditions could have a close relationship. Thus, we sought to determine the trends in annual rate of VTE occurrence in patients with ST-segment elevation myocardial infarction (STEMI) and measure its impact on in-hospital mortality, bleeding complications, and cost and length of hospitalization. We queried the 2003-2013 Nationwide Inpatient Sample databases to identify adults with primary diagnosis of STEMI. VTE events were then allocated. Inpatient outcomes of patients with VTE were compared to those without VTE. Out of 2,495,757 hospitalizations for STEMI, VTE was diagnosed in 25,149 (1%) hospitalizations. Patients who experienced VTE were older (mean age: 67.5 vs 64.8, p < 0.01) and had a higher proportion of black patients (10.1% vs 7.7%, p < 0.001) and females (40.1% vs 35%, p < 0.001) compared to patients without VTE. There was an increasing trend in the rate of VTE during the study period (2003: 0.8% vs 2013: 1.0%, p < 0.001). Patients with VTE had a prolonged hospitalization (median: 9 vs 3 days, p < 0.001), increased cost, higher risk of gastrointestinal bleeding (OR: 2.13, p < 0.001), intracranial hemorrhage (OR: 2.14, p < 0.001), blood transfusions (OR: 1.94, p < 0.001), and mortality (OR: 1.39, p < 0.001). The rate of VTE occurrence in patients with STEMI in our study was 10 per 1000 admissions. VTE was associated with more bleeding complications, longer hospital stays, higher costs, and mortality. These findings suggest that a more aggressive approach for VTE prophylaxis may be warranted in this population.

Analysis of venous thromboembolism in neurosurgical patients undergoing standard versus routine ultrasonography.

Routine screening of high-risk asymptomatic trauma or surgical patients for venous thromboembolism (VTE) is controversial. Studies suggest against screening while others recognize that some patients at high risk may benefit. The purpose of this pilot study is to evaluate the benefit of routine screening using doppler ultrasonography for the early detection of deep venous thrombosis (DVT) in post-operative neurosurgical patients. This was a quasi-experimental study at a major academic tertiary care medical center. A total of 157 adults underwent cranial or spinal surgical interventions from March through August 2017 and received either standard screening (n = 104) versus routine ultrasonography screening (n = 53). There was no significant difference in incidence of DVT between the two groups: 11 (11%) in the standard screening group versus 5 (9%) in the routine screening group, p = 0.823. Upper and lower extremity ultrasonography was performed in 43 (41%) of the standard screening group versus 53 (100%) in the routine screening group, p < 0.001. DVT was identified in nearly one of every 6 ultrasonography screenings in the standard screening group versus 27 ultrasonography screenings required to identify one DVT in the routine screening group. There were the same number of screenings for upper extremity ultrasonography, but they did not yield or detect DVT; instead only superficial, untreatable, DVTs were reported. Total cost to diagnose one DVT, including screening and labor, averaged $13,664 in the standard group versus $56,525 in the routine group. Routine screening in neurosurgical patients who received VTE prophylaxis was not associated with lower incidence of VTE and mortality attributed to PE. Thus, routine screening may not be cost effective to prevent complications from DVT incidence.

Trends and Outcomes of Venous Thromboembolism in Hospitalized Patients With Ovarian Cancer: Results From Nationwide Inpatient Sample Database 2003 to 2011.

OBJECTIVE: Venous thromboembolism (VTE) is a major cause of mortality and morbidity in hospitalized patients with malignancy. Nationwide Inpatient Sample database was analyzed to determine the trends in the rate of hospitalization and mortality from VTE in hospitalized ovarian cancer patients and assess its economic impact and resource utilization. METHOD: We queried the 2003 to 2011 Nationwide Inpatient Sample database from Healthcare Cost and Utilization project (Agency of Healthcare Research and Quality) to identify all adults (age ≥18 years) ovarian cancer. Patients hospitalized with VTE as one of the top 3 discharge diagnoses were also identified. Demographic characteristics and in-hospital outcomes of this population were compared with ovarian cancer patients without VTE. Binary logistic regression analysis was used to obtain adjusted odds ratios (ORs). RESULTS: A total of 34,249 (3.5%) of a total of 981,386 hospitalized ovarian cancer patients had an accompanying diagnosis of VTE. Mean age of the study population was 64 years. After adjusting for potential confounders, compared with those without VTE, ovarian cancer patients with VTE had significantly higher inpatient mortality (6.2% vs 4.3%; OR, 1.12 [confidence interval (CI), 1.06-1.17]; P < .001), longer length of stay (5 vs 4 days; OR, 1.40 [CI, 1.36-1.43]; P < .001), higher average cost of hospitalization (US $26,000 vs US $22,000; OR, 1.10 [CI, 1.07-1.13]; P < .001), and greater disability at discharge (OR, 1.34 [CI, 1.31-1.38]; P < .001). Although the annual number of VTE admissions in ovarian cancer patients increased, in-hospital mortality declined from 10.9% in 2003 to 5.3% in 2011. CONCLUSIONS: Venous thromboembolism in hospitalized patients with ovarian cancer is associated with higher inpatient mortality, length of stay, higher cost of hospitalization, and disability at discharge. The hospitalization rate has increased, but the inpatient mortality rate has declined over study period.

Morbidity, mortality and costs associated with venous thromboembolism in hospitalized patients with cancer.

BACKGROUND: Venous thromboembolism (VTE) represents a leading cause of morbidity and mortality among patients with cancer. METHODS: Hospitalization data reported on adult cancer patients at US medical centers between 1995 and 2012 were analyzed. Cancer diagnosis, presence of VTE, comorbidities, and infectious complications were based on ICD-9-CM codes. RESULTS: Nearly six million hospitalizations of 3,146,388 individual patients with cancer were reported with VTE observed in 8.4%. A single hospitalization was randomly selected for each patient with VTE diagnosed in 166,537 (5.3%) of evaluated admissions. In-hospital mortality was observed in 5.5% of patients without a VTE diagnosis and in 15.0% of those with VTE including 19.4% with a pulmonary embolism. While rates of VTE increased from 3.5% in 1995 to 6.5% in 2012, no significant reported changes in VTE imaging, length of stay (LOS) or intensive care unit (ICU) admissions were observed and mortality decreased by one-third. VTE was reported in 5.2%, 5.8% and 5.4% of patients with solid tumors, lymphoma, and leukemia, respectively. Rates of VTE were greatest among patients with pancreatic, gastric or other abdominal malignancies as well as those with ovarian, lung and esophageal cancers. The risk of VTE increased progressively from 2.3% in those with no comorbidities to over 11% in those with ≥3 major comorbidities. The strongest risk factors for VTE were infectious complications including sepsis, invasive candidiasis, pneumonia and IV line infections. Average costs per hospitalization adjusted to 2015 dollars for patients without and with VTE were $19,994 and $37,352, respectively. CONCLUSIONS: VTE among hospitalized patients with cancer has increased significantly with a major impact on hospital mortality and costs. Patients with major medical comorbidities and infectious complications are at particularly high risk.

Clinical impact of application of risk assessment models (Padua Prediction Score and Improve Bleeding Score) on venous thromboembolism, major hemorrhage and health expenditure associated with pharmacologic VTE prophylaxis: a "real life" prospective and retrospective observational study on patients hospitalized in a Single Internal Medicine Unit (the STIME study).

International guidelines recommend the use of pharmacological prophylaxis in hospitalized medical patients at high risk of venous thromboembolism (VTE). The same international guidelines suggest the employment of standardized risk assessment models (RAMs) when evaluating the administration of pharmacological prophylaxis in acutely ill medical patients. The Padua Prediction Score and the Improve Bleeding Score have been indicated as the best available RAMs to predict thrombotic and haemorrhagic risk in hospitalized medical patients, but it is still unknown whether their combined use may lead to a significant reduction in thrombotic and haemorrhagic events. It is also unclear whether their extensive use can affect to some extent health expenditure associated with pharmacological VTE prophylaxis. The purpose of this single-centre, prospective and retrospective observational study is to investigate these unanswered questions. All patients admitted to our Internal Medicine Department between May 2015 and August 2015, i.e., before the introduction and extensive use of RAMs, were consecutively enrolled (retrospective group). Similarly, all patients admitted between November 2016 and February 2017-once RAMs clinical use became a consolidated practice-have also been consecutively recruited (prospective group). Consecutively, 203 patients were enrolled in the retrospective group and 210 patients were enrolled in the prospective group. Three events of major bleeding and one event of pulmonary embolism were observed in the prospective group; three events of major hemorrhage and two events of pulmonary embolism were observed in the retrospective group (p = not significant). A statistically significant decrease in pharmacological VTE prophylaxis among study groups was detected: 43.3% of prospective group patients and 56.7% of retrospective group patients received pharmacological prophylaxis (p = .028). Overall, 299 drug doses for VTE prophylaxis have been spared after RAMs introduction (p = .0001) and health expenditure decreased by 27.2% (i.e., 1.67 € saved for each single patient). In conclusion, the extensive use of RAMs in our population of hospitalized medical patients did not statistically affect VTE rate or incidence of major bleeding, but it resulted in a significant drop in health expenditure related with pharmacological prophylaxis. Awaiting new clinical trials, a broad use of RAMs may be a safe strategy for reducing health expenditure associated with VTE prophylaxis in hospitalized medical patients.

Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study.

Objective To determine the safety of direct oral anticoagulant (DOAC) use compared with warfarin use for the treatment of venous thromboembolism.Design Retrospective matched cohort study conducted between 1 January 2009 and 31 March 2016.Setting Community based, using healthcare data from six jurisdictions in Canada and the United States.Participants 59 525 adults (12 489 DOAC users; 47 036 warfarin users) with a new diagnosis of venous thromboembolism and a prescription for a DOAC or warfarin within 30 days of diagnosis.Main outcome measures Outcomes included hospital admission or emergency department visit for major bleeding and all cause mortality within 90 days after starting treatment. Propensity score matching and shared frailty models were used to estimate adjusted hazard ratios of the outcomes comparing DOACs with warfarin. Analyses were conducted independently at each site, with meta-analytical methods used to estimate pooled hazard ratios across sites.Results Of the 59 525 participants, 1967 (3.3%) had a major bleed and 1029 (1.7%) died over a mean follow-up of 85.2 days. The risk of major bleeding was similar for DOAC compared with warfarin use (pooled hazard ratio 0.92, 95% confidence interval 0.82 to 1.03), with the overall direction of the association favouring DOAC use. No difference was found in the risk of death (pooled hazard ratio 0.99, 0.84 to 1.16) for DOACs compared with warfarin use. There was no evidence of heterogeneity across centres, between patients with and without chronic kidney disease, across age groups, or between male and female patients.Conclusions In this analysis of adults with incident venous thromboembolism, treatment with DOACs, compared with warfarin, was not associated with an increased risk of major bleeding or all cause mortality in the first 90 days of treatment.Trial registration Clinical trials NCT02833987.

Prostate cancer-specific survival among warfarin users in the Finnish Randomized Study of Screening for Prostate Cancer.

BACKGROUND: Venous thromboembolic events (VTE) are common in cancer patients and associated with higher mortality. In vivo thrombosis and anticoagulation might be involved in tumor growth and progression. We studied the association of warfarin and other anticoagulant use as antithrombotic medication and prostate cancer (PCa) death in men with the disease. METHODS: The study included 6,537 men diagnosed with PCa during 1995-2009. Information on anticoagulant use was obtained from a national reimbursement registry. Cox regression with adjustment for age, PCa risk group, primary therapy and use of other medication was performed to compare risk of PCa death between warfarin users with 1) men using other types of anticoagulants and 2) non-users of anticoagulants. Medication use was analyzed as a time-dependent variable to minimize immortal time bias. RESULTS: In total, 728 men died from PCa during a median follow-up of 9 years. Compared to anticoagulant non-users, post-diagnostic use of warfarin was associated with an increased risk of PCa death (overall HR 1.47, 95% CI 1.13-1.93). However, this was limited to low-dose, low-intensity use. Otherwise, the risk was similar to anticoagulant non-users. Additionally, we found no risk difference between warfarin and other types of anticoagulants. Pre-diagnostic use of warfarin was not associated with the risk of PCa death. CONCLUSIONS: We found no reduction in risk of PCa death associated with warfarin use. Conversely, the risk was increased in short-term use, which is probably explained by a higher risk of thrombotic events prompting warfarin use in patients with terminal PCa.

Economic evaluation of strategies for restarting anticoagulation therapy after a first event of unprovoked venous thromboembolism.

Essentials Correct duration of treatment after a first unprovoked venous thromboembolism (VTE) is unknown. We assessed when restarting anticoagulation was worthwhile based on patient risk of recurrent VTE. When the risk over a one-year period is 17.5%, restarting is cost-effective. However, sensitivity analyses indicate large uncertainty in the estimates. SUMMARY: Background Following at least 3 months of anticoagulation therapy after a first unprovoked venous thromboembolism (VTE), there is uncertainty about the duration of therapy. Further anticoagulation therapy reduces the risk of having a potentially fatal recurrent VTE but at the expense of a higher risk of bleeding, which can also be fatal. Objective An economic evaluation sought to estimate the long-term cost-effectiveness of using a decision rule for restarting anticoagulation therapy vs. no extension of therapy in patients based on their risk of a further unprovoked VTE. Methods A Markov patient-level simulation model was developed, which adopted a lifetime time horizon with monthly time cycles and was from a UK National Health Service (NHS)/Personal Social Services (PSS) perspective. Results Base-case model results suggest that treating patients with a predicted 1 year VTE risk of 17.5% or higher may be cost-effective if decision makers are willing to pay up to £20 000 per quality adjusted life year (QALY) gained. However, probabilistic sensitivity analysis shows that the model was highly sensitive to overall parameter uncertainty and caution is warranted in selecting the optimal decision rule on cost-effectiveness grounds. Univariate sensitivity analyses indicate variables such as anticoagulation therapy disutility and mortality risks were very influential in driving model results. Conclusion This represents the first economic model to consider the use of a decision rule for restarting therapy for unprovoked VTE patients. Better data are required to predict long-term bleeding risks during therapy in this patient group.

Sex-based disparities in venous thromboembolism outcomes: A National Inpatient Sample (NIS)-based analysis.

Venous thromboembolism (VTE) contributes to significant morbidity, mortality, and socioeconomic burden. There is a paucity of literature regarding sex-based sociodemographic differences in VTE presentation and short-term outcomes. We aimed to compare clinical outcomes between men and women hospitalized for VTE management. We performed a retrospective analysis using data from the National Inpatient Sample (NIS) database from 2012 to 2013. Inclusion criteria were age 18 years and older and a primary discharge diagnosis of VTE. Sociodemographic features and medical comorbidities were analyzed, as were hospital length of stay and in-hospital mortality rates. A total of 107,896 patients met the inclusion criteria; 53% were female. Median age was 65 years (interquartile range 51-77) and women were older than men (65 vs 62 years, p<0.001). There were significant differences between men and women with respect to race, primary insurance payer and medical comorbidities, and small differences with respect to VTE location. Female sex was associated with a small but significantly longer hospital length of stay (mean ratio 1.04, 95% CI 1.03-1.05, p<0.001) but no significant difference in in-hospital mortality (2.2% vs 2.1%, p=0.15). In a multivariate model, there was no significant difference between women and men with respect to hospital length of stay or in-hospital mortality. In conclusion, we used data from the NIS to study over 100,000 patients hospitalized for VTE, and identified several sex-based disparities in sociodemographic factors and location of VTE. However, in a multivariable analysis correcting for these factors, sex was not associated with significant differences in clinical outcomes.

Risk assessment models for venous thromboembolism in acutely ill medical patients. A systematic review.

Although the use of thromboprophylaxis is recommended for acutely ill medical patients at increased risk of venous thromboembolism (VTE), it remains unclear which risk assessment model (RAM) should be routinely used to identify at-risk patients requiring thromboprophylaxis. We therefore aimed to describe existing RAMs, and to compare these tools in terms of validity and applicability for clinical decision-making. We performed a comprehensive systematic search in MEDLINE from the date of initiation until May 2016 for studies in acutely ill medical patients investigating validity of RAMs for VTE. Two reviewers independently screened the title, abstract, and full text, and evaluated the characteristics of studies, and the composition, evidence of validation, and results on validity of the RAMs. We included 11 studies assessing eight RAMs: 4-Element RAM, Caprini RAM, a full logistic model, Geneva risk score, IMPROVE-RAM, Kucher Model, a "Multivariable Model", and Padua Prediction Score. The 4-Element RAM, IMPROVE-RAM, Multivariable Model, and full logistic model had derivation by identifying factors with predictive power. The other four RAMs were empirically generated based on consensus guidelines, published data, and clinical expertise. The Kucher Model, the Padua Prediction Score, the Geneva Risk Score and the IMPROVE-RAM underwent multicenter external validation. The Kucher Model, the Padua Prediction Score, and the Geneva Risk Score improved rates of thromboprophylaxis or clinical outcomes. In conclusion, existing RAMs to evaluate the need of thromboprophylaxis in acutely ill medical patients are difficult to compare and none fulfills the criteria of an ideal RAM. Nevertheless, the adequacy of thromboprophylaxis may be improved by implementing one of the validated RAMs.

Venous thromboembolism incidence, recurrence, and mortality based on Women's Health Initiative data and Medicare claims.

INTRODUCTION: Our objective was to compare Medicare claims to physician review and adjudication of medical records for identifying venous thromboembolism (VTE), and to assess VTE incidence, recurrence, and mortality in a large national cohort of post-menopausal women followed up to 19years. MATERIALS AND METHODS: We used detailed clinical data from the Women's Health Initiative (WHI) linked to Medicare claims. Agreement between data sources was evaluated among 16,003 women during 1993-2010. A claims-based definition was selected to analyze VTE occurrence and impact among 71,267 women during 1993-2012. RESULTS: Our VTE definition had 83% sensitivity. Positive predictive value was 69% when all records were included, and 94% after limiting Medicare records to those with a WHI hospitalization adjudicated. Annualized VTE incidence was 4.06/1000person-years (PY), recurrence was 5.30/100PY, and both rates varied by race/ethnicity. Post-VTE mortality within 1year was 22.49% from all causes, including 1.01% from pulmonary embolism, 10.40% from cancer, and 11.08% from other causes. Cancer-related VTE compared to non-cancer VTE had significantly (p<0.001) higher recurrence (9.86/100PY vs. 4.43/100PY) and mortality from all causes (45.89% vs. 12.28%), but not from pulmonary embolism (0.40% vs. 1.27%). CONCLUSIONS: Medicare claims compared reasonably well to physician adjudication. The combined data sources provided new insights about VTE burden and prognosis in older women.

Venous thromboembolism: role of pharmacists and managed care considerations.

Venous thromboembolism (VTE) includes deep vein thrombosis and pulmonary embolism. Anticoagulation is used in patients with VTE to reduce the risk of recurrent VTE and VTE-related death. The overall incidence of VTE is 1 to 2 per 1000 person-years. Long-term mortality for patients with VTE is poor, with 25% of patients not surviving 7 days and nearly 40% not surviving the first year. Coagulation disorders demand effective anticoagulant therapy to avoid complications, especially recurrent VTE and VTE-related death. For more than 60 years, warfarin has been the cornerstone of therapy for patients requiring anticoagulation and was the sole oral anticoagulant available in the United States until 2010. Since then, the FDA has approved 5 direct-acting oral anticoagulants (DOACs) that inhibit single coagulation factors (factor Xa and thrombin). DOACs provide predictable anticoagulation with fixed dosing, easier perioperative management, no routine laboratory monitoring, and fewer food-drug interactions. However, when choosing DOACs, clinicians must consider several issues in addition to efficacy and safety before employing these therapies, including patient-specific factors, adherence and persistence with therapy, and their cost-effectiveness for clinical use.